Devices, systems and methods for medicament delivery

ABSTRACT

An apparatus includes a label configured to be coupled to a medicament delivery device. The label includes a first surface and a second surface. The first surface is configured to be coupled to an outer surface of the medicament delivery device. The second surface includes a textual indicia. The label further includes an electronic circuit system configured to output an electronic signal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/404,699, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 24, 2012, which is a continuation of U.S. patentapplication Ser. No. 12/794,020, entitled “Devices, Systems and Methodsfor Medicament Delivery,” filed Jun. 4, 2010, now U.S. Pat. No.8,206,360, which is a continuation of U.S. patent application Ser. No.11/621,236, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Jan. 9, 2007, now U.S. Pat. No. 7,731,686, which is acontinuation-in-part of U.S. patent application Ser. No. 10/572,148,entitled “Devices, Systems and Methods for Medicament Delivery,” filedMar. 16, 2006, now U.S. Pat. No. 7,749,194, which is a national stagefiling under 35 U.S.C. §371 of International Patent Application No.PCT/US2006/003415, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 1, 2006, which claims priority to U.S. ProvisionalApplication Ser. No. 60/648,822, entitled “Devices, Systems and Methodsfor Medicament Delivery,” filed Feb. 1, 2005 and U.S. ProvisionalApplication Ser. No. 60/731,886, entitled “Auto-Injector with Feedback,”filed Oct. 31, 2005, each of which is incorporated herein by referencein its entirety. U.S. patent application Ser. No. 11/621,236 also claimspriority to U.S. Provisional Application Ser. No. 60/787,046, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Mar. 29,2006, which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to a medicament delivery device for delivering a medicamentinto a body of a patient.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

To actuate such a medicament delivery device, however, the user may berequired to execute a series of operations. For example, to actuate someknown auto-injectors, the user must remove a protective cap, remove alocking device, place the auto-injector in a proper position against thebody and then press a button to actuate the auto-injector. Failure tocomplete these operations properly can result in an incomplete injectionand/or injection into an undesired location of the body. In certaininstances, for example, users who have become confused in the operationof some known auto-injectors have inadvertently injected the medicamentinto their thumb by improperly positioning the auto-injector.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, and may therefore have no experience with the medicamentdelivery device. Similarly, because some known medicament deliverydevices are configured to be used relatively infrequently in response toan allergic reaction or the like, even those users familiar with thedevice and/or who have been trained may not be well practiced atoperating the device. Finally, such devices are often used during anemergency situation, during which even experienced and/or trained usersmay be subject to confusion, panic and/or the physiological effects ofthe condition requiring treatment.

Some known medicament delivery devices include printed instructions toinform the user of the steps required to properly deliver themedicament. Such printed instructions, however, can be inadequate forthe class of users and/or the situations described above. Moreover,because some known medicament delivery devices, such as, for example,auto-injectors, pen injectors, inhalers or the like, can be compact,such printed instructions may be too small to read and comprehend duringan emergency situation.

Some known medicament delivery devices include and electronic system toassist the user in setting the proper dosage and/or maintaining acompliance log. Such known medicament delivery devices and theaccompanying electronic systems can be large and therefore notconveniently carried by the user. Moreover, such known medicamentdelivery devices and the accompanying electronic systems can becomplicated and/or expensive to manufacture.

Thus, a need exists for a medicament delivery device and/or a medicamentcontainer that can be conveniently carried by a user, that providesinstructions that can be easily understood by an untrained user in anytype of situation, and that can be inexpensively manufactured.

SUMMARY

Medicament delivery devices are described herein. In one embodiment, anapparatus includes a label configured to be coupled to a medicamentdelivery device. The label includes a first surface and a secondsurface. The first surface is configured to be coupled to an outersurface of the medicament delivery device. The second surface includes atextual indicia. The label further includes an electronic circuit systemconfigured to output an electronic signal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medicament delivery device accordingto an embodiment of the invention.

FIG. 2 is a front cross-sectional view of the medicament delivery deviceshown in FIG. 1.

FIG. 3 is a schematic illustration of a portion of the medicamentdelivery device shown in FIG. 1.

FIG. 4 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIG. 5 is a perspective view of an auto-injector according to anembodiment of the invention.

FIG. 6 is a front view of the auto-injector illustrated in FIG. 5, witha portion of the auto-injector illustrated in phantom lines for ease ofreference.

FIG. 7 is a partial cut-away front view of a portion of theauto-injector illustrated in FIG. 5.

FIG. 8 is a cross-sectional view of a portion of the auto-injectorillustrated in FIG. 5 taken along line 8-8 in FIG. 7.

FIG. 9 is a cross-sectional view of a portion of the auto-injectorillustrated in FIG. 5 taken along line 9-9 in FIG. 7.

FIG. 10 is a front view of a portion of the auto-injector illustrated inFIG. 5.

FIG. 11 is a schematic illustration of a portion of the auto-injectorillustrated in FIG. 5.

FIG. 12 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a second configuration.

FIG. 13 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a third configuration.

FIG. 14 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a fourth configuration.

FIGS. 15 and 16 are front views of a portion of the auto-injectorlabeled as region 15 in FIG. 10, in a first configuration and a secondconfiguration, respectively.

FIGS. 17 through 20 are perspective views of a portion of theauto-injector illustrated in FIG. 10, in a first configuration, a secondconfiguration, a third configuration and a fourth configuration,respectively.

FIG. 21 is a flow chart of a method according to an embodiment of theinvention.

FIG. 22 is a flow chart of a method according to an embodiment of theinvention.

FIG. 23 is a flow chart of a method according to an embodiment of theinvention.

FIGS. 24 and 25 are perspective views of a medicament delivery deviceaccording to an embodiment of the invention.

FIG. 26 is a perspective view of the auto-injector illustrated in FIG. 5in a first configuration, with at least a portion of the auto-injectorillustrated in phantom lines for ease of reference.

FIG. 27 is a front view of the auto-injector illustrated in FIGS. 5 and26 in a first configuration.

FIG. 28 is a perspective view of the auto-injector illustrated in FIG.26 showing an assembly according to an embodiment of the invention beingremoved.

FIG. 29 is a front view of the auto-injector illustrated in FIG. 26showing a member according to an embodiment of the invention beingremoved.

FIG. 30 is a perspective view of a member of the auto-injectorillustrated in FIG. 29.

FIG. 31 is a perspective view of a portion of the auto-injectorillustrated in FIG. 29.

FIG. 32 is a perspective view of a portion of the auto-injectorillustrated in FIG. 31.

FIG. 33 is a partially exploded perspective view of a base of theauto-injector illustrated in FIG. 31.

FIG. 34 is a front view of the auto-injector illustrated in FIG. 27 in asecond configuration.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a label configured to becoupled to a medicament delivery device. The label includes a firstsurface and a second surface. The first surface is configured to becoupled to an outer surface of the medicament delivery device. In someembodiments, for example, the first surface can include an adhesive. Thesecond surface includes a textual indicia, such as, for example, adescription of the medicament delivery device, a mark indicating themanufacturer or distributor of the medicament delivery device and/or aninstruction associated with the use of the medicament delivery device.The label further includes an electronic circuit system configured tooutput an electronic signal. In some embodiments, the electronic signalcan include an instruction associated with the use of the medicamentdelivery device.

In some embodiments, an apparatus includes a printed circuit boardconfigured to be coupled to a medicament delivery device. The printedcircuit board includes a substrate and an electrical conductor disposedon the substrate. The substrate includes an actuation portion configuredto receive an actuator. The actuator is configured to deform theactuation portion of the substrate, thereby separating the electricalconductor.

In some embodiments, an apparatus includes a printed circuit boardconfigured to be coupled to a medicament delivery device. The printedcircuit board includes a substrate and an electrical conductor disposedon the substrate. The substrate includes an actuation portion configuredto receive an actuator. The actuation portion of the substrate definesan opening adjacent the electrical conductor, the opening beingconfigured to receive the actuator. The actuator is configured to movesubstantially parallel to a plane defined by a surface of the actuationportion of the substrate to produce a tear in the actuation portion ofthe substrate, thereby severing the electrical conductor. In someembodiments, the opening can be configured to propagate the tear in apredetermined direction.

In some embodiments, an apparatus includes a medicament delivery deviceconfigured to deliver a medicament into a body. The medicament deliverydevice, which can be, for example, a pen injector, an auto-injector, aninhaler or a transdermal delivery device, includes an electronic circuitsystem and a locking member. The electronic circuit system is configuredto output an electronic signal associated with a use of the medicamentdelivery device. In some embodiments, the electronic signal can be, forexample, associated with recorded speech. The locking member isconfigured to prevent the medicament from being delivered into the body.The locking member includes an actuator configured to actuate theelectronic circuit system.

In some embodiments, an apparatus includes a medicament delivery deviceconfigured to deliver a medicament into a body. The medicament deliverydevice includes an electronic circuit system and a locking member. Theelectronic circuit system includes a switch and is configured to outputa signal when the switch is moved from a first state to a second state.The locking member is configured to prevent the medicament from beingdelivered into the body when in a first position and to allow themedicament to be delivered into the body when in a second position. Aportion of the locking member is configured to move the switch from thefirst state to the second state when the locking member is moved fromthe first position to the second position.

In some embodiments, an apparatus includes a housing configured tocontain a medicament, a flexible printed circuit board, an energystorage member and a label. The flexible printed circuit board isdisposed on an outer surface of the housing and includes a firstelectrical contact portion and a second electrical contact portion. Thelabel is coupled to the flexible printed circuit board and the housingand is configured to maintain a first surface of the energy storagemember in electrical communication with the first electrical contactportion and maintain a second surface of the energy storage member inelectrical communication with the second electrical contact portion. Theenergy storage member, can be, for example, a battery.

In some embodiments, a method includes assembling a medicament deliverydevice, such as, for example, an auto-injector. An electronic circuitsystem is then placed against an outer surface of the medicamentdelivery device. A label is then coupled to the medicament deliverydevice such that the label is disposed about a portion of the electroniccircuit system.

FIGS. 1 and 2 are a perspective view and a partial cutaway front view,respectively, of an auto-injector 1002 according to an embodiment of theinvention. The auto-injector 1002 is similar to the auto-injectorsdescribed in U.S. patent application Ser. No. 11/562,061, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Nov. 21,2006, which is incorporated herein by reference in its entirety.Accordingly, only an overview of the mechanical components and relatedoperation of the auto-injector 1002 is included below.

The auto-injector 1002 includes a housing 1110 that defines a gaschamber 1120. The housing 1110 has a proximal end portion 1112 and adistal end portion 1114. A base 1520 is movably coupled to the distalend portion 1114 of the housing 1110. A safety lock 1710 is removablycoupled to the base 1520. As discussed in more detail herein, when thesafety lock 1710 is coupled to the base 1520, the auto-injector 1002cannot be actuated. When the safety lock 1710 is removed from the base1520, the base 1520 can be moved relative to the housing 1110, therebyactuating the auto-injector 1002. Accordingly, to inject a medicamentinto the body, the distal end portion 1114 of the housing 1110 isoriented towards the user such that the base 1520 is in contact with theportion of the body where the injection is to be made. The base 1520 isthen moved towards the proximal end 1112 of the housing 1110 to actuatethe auto-injector 1002.

The auto-injector 1002 includes a medicament injector 1210 and a systemactuator 1510 disposed non-coaxially within the housing 1110. Themedicament injector 1210 includes multiple medicament vials 1262, aplunger 1284 movably disposed within each medicament vial 1262, amovable member 1312 engaged with each plunger 1284 and a needle 1212.Retraction springs 1350 located within a portion of the base 1520 andthe housing 1110 can push the needle 1212 back within the housing 1110after injection. The system actuator 1510 includes a compressed spring1560, a compressed gas cylinder 1412, and a puncturing mechanism 1612 todispel the contents of the compressed gas cylinder 1412.

In use, when the auto-injector 1002 is actuated, the puncturingmechanism 1612 punctures the compressed gas cylinder 1412 allowing apressurized gas to flow into the gas chamber 1120. In response to aforce produced by the pressurized gas on the movable member 1312, themovable member 1312 moves distally within the housing 1110. As a result,the needle 1212 is extended through the housing 1110. The movement ofthe movable member 1312 also causes the plungers 1284 to move within thevials 1262, thereby expelling a medicament from the vials 1262.

The auto-injector 1002 includes an electronic circuit system 1920 toprovide a predetermined sequence of electronic outputs during the use ofthe auto-injector 1002. The electronic circuit system 1920 is powered bya battery (not shown in FIGS. 1 and 2) and includes a processor (notshown in FIGS. 1 and 2), a start button 1970, two switches 1972A and1972B, a proximity sensor 1974, two visual output devices 1958A and1958B and an audio output device 1956. The components of the electroniccircuit system 1920 are operatively coupled by any suitable mechanism,such as, for example, a printed circuit board (not shown in FIGS. 1 and2) having conductive traces.

The start button 1970 is disposed on the proximal end of the housing1110 and can be manually actuated by the user to begin the sequence ofelectronic outputs. The first switch 1972A is disposed on the distalportion 1114 of the housing 1110 adjacent the base 1520 and the lockingmember 1710. The locking member 1710 is configured to engage the firstswitch 1972A such that when the locking member 1710 is removed, as shownin FIG. 1, the first switch 1972A changes states. In this manner,removal of the locking member 1710 can trigger the processor to output apredetermined electronic output.

Similarly, the second switch 1972B is disposed on the housing 1110adjacent the medicament injector 1210. The medicament injector 1210 isconfigured to engage the second switch 1972B such that when themedicament injector 1210 is moved distally within the housing 1110 thesecond switch 1972B changes states. In this manner, the processor can beprompted to output a predetermined electronic output based on theposition of the medicament injector 1210.

The proximity sensor 1974 is disposed on the base 1520 and is configuredto produce an output when the base 1520 engages the body. The proximitysensor can be, for example, a temperature sensor, an optical sensor orthe like. In this manner, the processor can be prompted to output apredetermined electronic output when the base 1520 is positioned againstthe body.

The first visual output device 1958A is disposed on the locking member1710. Similarly, the second visual output device 1958B is disposed onthe outer surface 1111 of the housing 1110. The visual output devices1958A and 1958B are in electronic communication with the processor andare configured to produce an output in response to an electronic signaloutput by the processor. The visual output devices 1958A and 1958B canbe any suitable visual indicia, such as, light-emitting diodes (LEDs),liquid-crystal display (LCD) screens, optical polymers, fiber opticcomponents or the like. In some embodiments, the visual output devices1958A and 1958B can be coupled to the housing 1110 and/or the lockingmember 1710 by a label 1910.

The audio output device 1956 is disposed within the housing 1110 suchthat it can project sound outside of the housing 1110. The audio outputdevice 1956 can be any suitable device for producing sound, such as amicro-speaker a piezo-electric transducer or the like. Such sound outputcan include, for example, an alarm, a series of beeps, recorded speechor the like. The audio output device 1956 is in electronic communicationwith the processor and is configured to produce an output in response toan electronic signal output by the processor.

In use, the user activates the electronic circuit system by pushing thestart button 1970 to activate the processor, thereby causing theprocessor to output a predetermined sequence of electronic outputs. Insome embodiments, the start button 1970 can activate the processor byproviding an input to the processor. In other embodiments, the startbutton 1970 can activate the processor by placing the battery (not shownin FIGS. 1 and 2) in electronic communication with the processor.

In some embodiments, upon activation, the processor can output anelectronic signal to the audio output device 1956 thereby producing afirst electronic output instructing the user in how to use theauto-injector 1002. Such a message can state, for example, “pleaseremove the safety tab.” Additionally, the first visual output device1958A can produce a flashing light to further indicate to the user wherethe locking member 1710 is located. The processor can be configured torepeat the first audible instruction if the locking member 1710 is notremoved within a predetermined time period.

When the user removes the locking member 1710, the first switch 1972Achanges states thereby triggering the processor to output an electronicoutput providing a second instruction to the user. The secondinstruction can be, for example, an audible speech output instructingthe user to “please place the base of the device on the outer portion ofyour thigh.” The first visual output device 1958A can produce a lightedoutput during this audible instruction, thereby visually indicatingwhere the base 1520 is located and/or what portion of the base 1520should be placed on the thigh.

When the user places the base 1520 against the body, the proximitysensor 1974 provides an input to the processor, thereby triggering theprocessor to output an electronic output providing a third instructionto the user. The third instruction can be, for example, an audiblespeech output instructing the user to “push down on the top of thedevice to activate the injector.”

When the injection is completed, the medicament injector 1210 isconfigured to engage the second switch 1972B, thereby triggering theprocessor to output an electronic output providing a fourth instructionto the user. Such a post-use instruction can be, for example, an audiblespeech output instructing the user to seek further medical attention,providing instructions for the safe disposal of the auto-injector 1002or the like.

FIG. 3 is a schematic illustration of the electronic circuit system 1920of the auto-injector 1002. The electronic circuit system 1920 includes aprocessor 1950 operatively coupled to a memory device 1954. The memorydevice 1954 can be configured to store processor-readable code 1955instructing the processor 1950 to perform the functions described above.In some embodiments, the processor-readable code 1955 can be modifiedand/or updated as circumstances dictate. The electronic circuit system1920 includes an input/output device 1952 configured to receiveelectronic inputs from the switches 1972A and 1972B, the proximitysensor 1974 and/or the start button 1970. The input/output device 1952is also configured to provide electronic signals to the various outputdevices, such as the visual output devices 1958A and 1958B and the audiooutput device 1956.

The electronic circuit system 1920 also includes a network interface1953 configured to couple the electronic circuit system 1920 to acommunications network. Such an arrangement can be used, for example, todownload replacement processor-readable code 1955 from a central network(not shown) to the memory device 1954. The network interface 1953 canalso be configured to transmit information from the electronic circuitsystem 1920 to a central network, the user's home computer, the user'scell phone or the like.

FIG. 4 is a schematic illustration of a medical device 2002 according toan embodiment of the invention. The medical device 2002, which can be,for example, a medicament delivery device such as an auto-injector, apen injector, an inhaler, a transdermal delivery system or the like,includes a housing 2110 and a label 2910. The label 2910 is coupled toan outer surface 2111 of the housing 2110. The label 2910 includes afirst surface 2912, a second surface 2914 and an electronic circuitsystem 2920. The first surface 2912 is configured to engage the outersurface 2111 of the housing 2110 to couple the label 2910 to the housing2110. In some embodiments, the first surface 2912 can include anadhesive to fixedly couple the label 2910 to the housing 2110. Thesecond surface 2914 includes a textual indicia 2916. The textual indicia2916 can include, for example, a description of the medicament deliverydevice, a source of the medicament delivery device and/or an instructionassociated with the use of the medicament delivery device. Although thefirst surface 2912 is shown as being opposite the second surface 2914,in other embodiments, the first surface 2912 and the second surface 2914can be adjacent each other and/or co-planar.

The electronic circuit system 2920 is configured to output an electronicsignal. As discussed in more detail herein, the electronic circuitsystem 2920 can include many components, such as, for example, aprocessor, a switch, a visual output device and/or an audio outputdevice. The electronic signal can be, for example, an electronic signalcommunicated to an output device, such as, for example, a visual outputdevice, an audio output device, a haptic output device or the like. Insome embodiments, the electronic signal can be associated with an aspectof the medical device 2002, such as an instruction associated with aninitial use of the medical device 2002. For example, in someembodiments, the electronic circuit system 2920 can output a textmessage to a display screen (not shown) disposed on the medical device2002 instructing the user in the use of the medical device 2002. Inother embodiments, the electronic circuit system 2920 can produce anaudio output, such as recorded speech, instructing the user in the useof the medical device 2002.

Although the electronic circuit system 2920 is shown as being disposedon the second surface 2914 of the label 2910, in other embodiments, theelectronic circuit system can be disposed on the first surface 2912 ofthe label 2910. In yet other embodiments, the electronic circuit system2920 can be disposed between the first surface 2912 and the secondsurface 2914 of the label 2910. In yet other embodiments, the label 2910can include multiple discrete layers coupled together, within whichportions of the electronic circuit system can be disposed.

FIG. 5 is a perspective view of an auto-injector 4002 according to anembodiment of the invention. The auto-injector 4002 is similar to theauto-injectors described in U.S. patent application Ser. No. 11/562,061,entitled “Devices, Systems and Methods for Medicament Delivery,” filedNov. 21, 2006, which is incorporated herein by reference in itsentirety. Accordingly, the mechanical components and operation of theauto-injector 4002 are not described in detail herein.

The auto-injector 4002 includes a housing 4110 having a proximal endportion 4112 and a distal end portion 4114. The distal end portion 4114of the housing 4110 includes a protrusion 4142 to help a user grasp andretain the housing 4110 when using the auto-injector 4002. Said anotherway, the protrusion 4142 is configured to prevent the auto-injector 4002from slipping from the user's grasp during use. A base 4520 is movablycoupled to the distal end portion 4114 of the housing 4110. A needleguard assembly 4810 is removably coupled to the base 4520. Similarly, asafety lock 4710 is removably coupled to the base 4520. To inject amedicament into the body, the distal end portion 4114 of the housing isoriented towards the user such that the base 4520 is in contact with theportion of the body where the injection is to be made. The base 4520 isthen moved towards the proximal end 4112 of the housing 4110 to actuatethe auto-injector 4002.

FIG. 26 is a perspective view of the auto-injector 4002 showing thehousing 4110 in phantom lines so that the components contained withinthe housing 4110 can be more clearly seen. Similarly, FIG. 27 is a frontview of the auto-injector 4002 showing the housing 4110 in phantomlines. For clarity, the auto-injector 4002 shown in FIGS. 26 and 27 showthe auto-injector 4002 without the needle guard assembly 4810′, thesafety lock 4710′ and the electronic circuit system 4920. Additionally,the auto-injector 4002 shown and described with reference to FIGS. 26-34is presented to describe the mechanical components and operation of thedevice. Accordingly, the auto-injector 4002 shown and described withreference to FIGS. 26-34 includes a needle guard assembly 4810′ thatdoes not include a battery isolation tab 4860 (see e.g. FIG. 12), asafety lock 4710′ that does not include an actuator 4732 (see e.g., FIG.13), and a base 4520′ that does not include an actuator 4538 (see e.g.,FIG. 14).

The auto-injector 4002 includes a medicament injector 4210 and a movablemember 4312 engaged with the medicament injector 4210, each of which aredisposed within the housing 4110. The auto-injector 4002 also includes asystem actuator 4510, a compressed gas container 4412 and a gas releasemechanism 4612. The medicament injector 4210 includes a carrier 4250that is movable within the housing 4110, a medicament container 4262 anda needle 4212. The medicament container 4262 is coupled to the carrier4250. The needle 4212 is disposed within a needle hub portion of thecarrier to allow the needle 4212 to be placed in fluid communicationwith the medicament container 4262 during an injection event.

The movable member 4312 includes a proximal end portion 4316 and adistal end portion 4318. The proximal end portion 4316 includes asurface 4322 that, together with the housing 4110, defines a gas chamber4120. Said another way, the surface 4322 defines a portion of a boundaryof the gas chamber 4120. The distal end portion 4318 is disposed withinthe medicament container 4262. In use, the movable member 4312 movestowards the distal end portion 4114 of the housing 4110, as indicated byarrow C in FIG. 26, in response to a force produced by a pressurized gason the surface 4322 of the movable member 4312. As a result, the movablemember 4312 and the medicament injector 4250 are moved towards thedistal end portion 4114 of the housing 4110, thereby exposing the needle4212 from the housing 4110. The movable member 4312 then continues tomove within the medicament container 4262 to expel a medicament from themedicament container 4262 through the needle 4212.

The auto-injector 4002 is actuated by the system actuator 4510, which isconfigured to move the compressed gas container 4412 into contact withthe gas release mechanism 4612. The gas release mechanism 4612 puncturesa portion of the compressed gas container 4412 to release thepressurized gas contained therein into the gas chamber 4120 defined bythe housing 4110. The system actuator 4510 includes a rod 4540, a spring4560 and a spring retainer 4570. The rod 4540 has a proximal end portion4542 and a distal end portion 4544. The proximal end portion 4542 of therod 4540 is coupled to the compressed gas container 4412. The distal endportion 4544 of the rod 4540 is coupled to the spring retainer 4570 bytwo projections 4548, which can be moved inwardly towards each other todecouple the rod 4540 from the spring retainer 4570, as discussed below.

The spring 4560 is disposed about the rod 4540 in a compressed statesuch that the spring 4560 is retained by the proximal end portion 4542of the rod 4540 and the spring retainer 4570. In this manner, the rod4540 is spring-loaded such that when the distal end portion 4544 of therod 4540 is decoupled from the spring retainer 4570, the force of thespring 4560 causes the rod 4540, and therefore the compressed gascontainer 4412, to move proximally as indicated by arrow D in FIG. 26and into contact with the gas release mechanism 4612.

The base 4520′ defines an opening 4522 configured to receive a portionof the projections 4548 when the base is moved towards the proximal end4112 of the housing 4110, as indicated by arrow E in FIG. 26. When theprojections 4548 are received within the opening 4522, they are movedtogether causing the distal end portion 4544 of the rod 4540 to bereleased from the spring retainer 4570.

As shown in FIGS. 26 and 27, the medicament injector 4210 defines alongitudinal axis Lm that is non-coaxial with the longitudinal axis Ledefined by the compressed gas container 4412. Accordingly, themedicament injector 4210, the compressed gas container 4412 and thesystem actuator 4510 are arranged within the housing 4110 such that thehousing has a substantially rectangular shape. Moreover, the non-coaxialrelationship between the medicament injector 4210 and the compressed gascontainer 4412 allows the auto-injector 4002 to be actuated bymanipulating the base 4520′, which is located at the distal end portion4114 of the housing 4110.

Prior to use, the auto-injector 4002 must first be enabled by firstremoving the needle guard 4810′ and then removing the safety lock 4710′.As illustrated by arrow G in FIG. 28, the needle guard 4810′ is removedby pulling it distally. As described in more detail below, removal ofthe needle guard 4810′ also removes the isolation tab 4860 (see FIG.12), thereby placing the batteries 4962 into electrical connection withthe electronic circuit system 4910 (not shown in FIGS. 26-34, forpurposes of clarity). Similarly, as illustrated by arrow H in FIG. 29,the safety lock 4710′ is removed by pulling it substantially normal tothe longitudinal axis Le of the compressed gas container 4412. Saidanother way, the safety lock 4710′ is removed by moving it in adirection substantially normal to the direction that the needle guard4810′ is moved. As described below, removal of the safety lock 4710′also actuates the electronic circuit system 4920 (not shown in FIGS.26-34, for purposes of clarity). The needle guard 4810′ and the safetylock 4710′ are cooperatively arranged to prevent the safety lock 4710′from being removed before the needle guard 4810′ has been removed. Suchan arrangement prevents the auto-injector 4002 from being actuated whilethe needle guard 4810′ is in place.

As shown in FIG. 30, the safety lock 4710′ is a U-shaped member having afirst end 4712 and a second end 4714. The second end 4714 of the safetylock 4710′ includes two extended portions 4716, each of which includesan inwardly facing protrusion 4718. When the safety lock 4710′ is in itsfirst (or locked) position, the extended portions 4716 extend around aportion of the base 4520′ to space the base 4520′ apart from the distalend portion 4114 of the housing 4110. As shown in FIG. 31, theprotrusions 4718 are configured engage a portion of the base 4520′ toremovably couple the safety lock 4710′ in its first position.Additionally, one of the extended portions 4716 defines a recess 4720that receives the sheath retainer 4840 when the needle guard 4810′ is inits first position.

The first end 4712 of the safety lock 4710′ includes a lockingprotrusion 4722 that extends inwardly. As shown in FIG. 31, when thesafety lock 4710′ is in its first position, the locking protrusion 4722extends between the projections 4548 of the rod 4540 and obstructs theopening 4522 of the base 4520′. In this manner, when the safety lock4710′ is in its first position, the base 4520′ cannot be movedproximally to allow the projections 4548 to be received within theopening 4522. The arrangement of the locking protrusion 4722 alsoprevents the projections 4548 from being moved inwardly towards eachother. Accordingly, when the safety lock 4710′ is in its first position,the auto-injector 4002 cannot be actuated.

The outer surface 4724 of the first end 4712 of the safety lock 4710′includes a series of ridges 4726 to allow the user to more easily gripthe safety lock 4710′. The outer surface 4724 of the first end 4712 ofthe safety lock 4710′ also includes an indicia 4728 to instruct the userin operating the auto-injector 4002. As shown in FIG. 30, the indicia4728 includes a numeral to indicate the order of operation and an arrowto indicate the direction in which the safety lock 4710′ should bemoved. In some embodiments, the indicia 4728 can include differentcolors, detailed instructions or any other suitable indicia to instructthe user. In other embodiments, the indicia 4728 can protrude from thesafety lock 4710′ to aid the user when grasping the safety lock 4710′.

After being enabled, the auto-injector 4002 can then be actuated bymoving the base 4520′ proximally towards the housing 4110, as indicatedby arrow I in FIG. 32. Additionally, as described below, movement of thebase 4520′ actuates the electronic circuit system 4920 (not shown inFIGS. 26-34, for purposes of clarity).

As shown in FIG. 33, the base 4520′ defines two openings 4536 thatreceive corresponding attachment protrusions 4150 disposed on the distalend portion 4114 of the housing 4110. In this manner, the movementand/or alignment of the base 4520′ relative to the housing 4110 isguided by the attachment protrusions 4150 and the openings 4536. Eachattachment protrusion 4150 is secured within its corresponding opening4536 by a lock washer 4534. The lock washers 4534 each define an opening4535 that receives a portion of the attachment protrusion 4150. The lockwashers 4534 are disposed within slots 4533 defined by the base 4520′ sothat the openings 4535 are aligned with the attachment protrusions 4150.The openings 4535 are configured to allow the lock washers 4534 to moveproximally relative to the attachment protrusions 4150, but to preventmovement of the lock washers 4534 distally relative to the attachmentprotrusions 4150. In this manner, when the attachment protrusions 4150are disposed within the openings 4535 of the lock washers 4534, the base4520′ becomes fixedly coupled to the housing 4110. Moreover, after thebase 4520′ is moved proximally relative to the housing 4110, the lockwashers 4534 prevent the base 4520′ from returning to its initialposition.

The base 4520′ also defines a needle opening 4532, a recess 4526 and tworetraction spring pockets 4531. The needle opening 4532 receives aportion of the needle guard 4810′ when the needle guard is in its firstposition. Additionally, when the auto-injector 4002 is actuated, theneedle 4212 extends through the needle opening 4532. The retractionspring pockets 4531 receive a portion of the retraction springs.

As shown in FIG. 33, the base 4520′ includes two opposing taperedsurfaces 4524 that define an opening 4522 configured to receive acorresponding tapered surface 4550 of the projections 4548 when the base4520′ is moved proximally towards the housing 4110. When the projections4548 are received within the tapered opening 4522, they are movedtogether as indicated by arrows J in FIG. 32. The inward movement of theprojections 4548 causes the rod 4540 to become disengaged from thespring retainer 4570, thereby allowing the rod 4540 to be movedproximally along its longitudinal axis as the spring 4560 expands.

Because the rod 4540 is coupled to the compressed gas container 4412,when the rod 4540 is moved from its first (engaged) position to itssecond (actuated) position, the compressed gas container 4412 is movedproximally within the housing 4110 into engagement with the gas releasemechanism 4612. FIG. 34 shows the auto-injector in a secondconfiguration, in which the compressed gas container 4412 is engagedwith the gas release mechanism 4612. When in the second configuration,the compressed gas contained within the compressed gas container 4412 isreleased to actuate the medicament injector 4210.

The pressurized gas produces a force that causes the movable member 4312and the medicament injector 4210 to move distally within the housing4110. The movement of the medicament injector 4210 causes the needle4212 to extend from distal end portion 4114 of the housing 4110 and thebase 4520. This operation can be referred to as the “needle insertion”operation. When the medicament injector 4210 has completed its movement(i.e., the needle insertion operation is complete), the movable member4312 continues to move the medicament container 4262 distally within thecarrier 4250. The continued movement of the medicament container 4262places the needle 4212 in fluid communication with the medicamentcontainer 4262, thereby allowing the medicament to be injected. Theforce from the pressurized gas also causes the movable member 4312 tomove within the medicament container 4262, thereby expelling themedicament through the needle 4212. This operation can be referred to asthe “injection operation.” Upon completion of the injection, thepressurized gas is released from the gas chamber 4120, thereby allowingthe medicament injector 4210 and the movable member 4312 to be movedproximally within the housing. This operation can be referred to as the“retraction operation.”

The auto-injector 4002 includes a label 4910 coupled to an outer surface4111 of the housing 4110. The label 4910 includes an outer layer 4911,an intermediate layer 4980 and an electronic circuit system 4920 (seeFIGS. 7-9). FIG. 6 is a front view of the auto-injector 4002 showing theouter layer 4911 of the label 4910 in phantom lines so that theintermediate layer 4980 and an electronic circuit system 4920 can bemore clearly seen. As shown in FIGS. 7-9, the outer layer 4911, which,in some embodiments, can be constructed from paper, has a first surface4912 and a second surface 4914 opposite the first surface 4912. Multipleindicia 4916 are disposed on the first surface 4912. The indicia 4916include a textual indicia 4916A and two symbolic indicia 4916B. Thetextual indicia 4916B can be written text describing the medicamentdelivery device, indicating a source of the medicament delivery deviceand/or instructing a user in the use of the medicament delivery device.The symbolic indicia 4916B can include, for example, arrows, pointers,trademarks, symbols describing the use of the medicament delivery deviceor the like. The label 4910 is coupled to the outer surface 4111 of thehousing 4110 such that the portion of the first surface 4912 includingthe indicia 4916 is visible.

A portion of the second surface 4914 of the outer layer 4911 can becoupled to the outer surface 4111 of the housing 4110 by any suitablemethod. For example, in some embodiments, the second surface 4914 of theouter layer 4911 includes an adhesive configured to bond the outer layer4911 to the outer surface 4111 of the housing 4110. Other portions ofthe second surface 4914 of the outer layer 4911 are adjacent theintermediate layer 4980 and portions of the electronic circuit system4920. In this manner, the outer layer 4911 of the label 4910 retains theintermediate, or spacer, layer 4980 and the electronic circuit system4920 in a predetermined position against the outer surface 4111 of thehousing 4110.

The outer layer 4911 of the label 4910 includes multiple openings 4917adjacent the audio output device 4956. In this manner, sound wavesproduced by the audio output device 4956 can be transmitted to an areaoutside of the housing 4110. Similarly, the outer layer 4911 of thelabel 4910 includes openings 4918 adjacent the light emitting diodes(LEDs) 4958A and 4958B to allow the user to see the visual output. Insome embodiments, the outer layer 4911 of the label 4910 can include atransparent portion adjacent the LEDs 4958A and 4958B to allow the userto see the visual output.

The electronic circuit system 4920 includes a printed circuit board 4922upon which a microprocessor 4950, two LEDs 4958A and 4958B, two switches4972A and 4972B and various electronic components 4951, such as, forexample, resistors, capacitors and diodes, are mounted. The electroniccircuit system 4920 also includes an audio output device 4956, such as,for example, a micro-speaker, coupled to the outer surface 4111 of thehousing 4110 adjacent the printed circuit board 4922. The printedcircuit board 4922 includes a substrate 4924 upon which a series ofelectrical conductors 4934, such as for example, copper traces, areetched. The substrate 4924 can be constructed from any material havingsuitable electrical properties, mechanical properties and flexibility,such as, for example Mylar®, Kapton® or impregnated paper.

A mask layer (not shown) is disposed over the substrate 4924 toelectrically isolate selected portions of the electrical conductors 4934from adjacent components. The electrical conductors 4934 operativelycouple the above-mentioned circuit components in a predeterminedarrangement. In this manner, the electronic circuit system 4920 can beconfigured to output, via the LEDs 4958A and 4958B and/or the audiooutput device 4956, a predetermined sequence of electronic outputsduring the use of the auto-injector 4002.

Power is supplied to the electronic circuit system 4920 by two batteries4962 connected in series. The batteries can be, for example, three volt,“watch-style” lithium batteries. As shown in FIG. 9, each of thebatteries 4962 has a first surface 4964 and a second surface 4966opposite the first surface. The first surface 4964 can be, for example,an electrically negative terminal. Similarly, the second surface 4966can be an electrically positive terminal. As discussed in more detailherein, the batteries 4962 are positioned such that a first electricalcontact portion 4936 of the printed circuit board 4922 can be placed incontact with the first surface 4964 of the battery 4962 and a secondelectrical contact portion 4938 of the printed circuit board 4922 can beplaced in contact with the second surface 4966 of the battery 4962. Inthis manner, the batteries 4962 can be operatively coupled to theelectronic circuit system 4920.

As shown in FIGS. 7 and 9, a battery isolation tab 4860 is movablydisposed between the first electrical contact portion 4936 of theprinted circuit board 4922 and the first surface 4964 of one of thebatteries 4962. The battery isolation tab 4860 can be constructed fromany electrically isolative material, such as, for example, Mylar®. Asdiscussed in more detail herein, in this manner, the batteries 4962 canbe selectively placed in electronic communication with the electroniccircuit system 4920.

The intermediate, or spacer, layer 4980 is disposed between the outerlayer 4911 and the electronic circuit system 4920. The intermediatelayer 4980 includes openings (not shown) within which various componentsof the electronic circuit system, such as, for example, the batteries4962 are disposed. The intermediate layer 4980 is sized to maintain apredetermined spacing between the various components included in thelabel 4910. The intermediate layer can be constructed from any suitablematerial, such as, for example, flexible foam having an adhesivesurface, polycarbonate or the like.

FIG. 10 is a front view of the electronic circuit system 4920 showingthe arrangement of the various components (i.e., the microprocessor4950, LEDs 4958A and 4958B, switches 4972A and 4972B, audio outputdevice 4956 or the like). FIG. 11 is a schematic illustration of theelectronic circuit system 4920.

The operation of the auto-injector 4002 and the electronic circuitsystem 4920 is now discussed with reference to FIGS. 12-14. Theactuation of the electronic circuit system 4920 includes severaloperations that are incorporated into the standard procedures for usingthe auto-injector 4002. In this manner, the user can actuate theelectronic circuit system 4920 without completing any additionaloperations.

Prior to use, the auto-injector 4002 is first enabled by removing theneedle guard 4810 and the safety lock 4710 (see FIGS. 12 and 13). Asillustrated by arrow AA in FIG. 12, the needle guard 4810 is removed bymoving it distally. The needle guard 4810 includes a sheath retainer4840 and a sheath 4820. The sheath 4820 is configured to receive aportion of the needle (not shown) when the needle guard 4810 is in afirst (or installed) position. The sheath retainer 4840 is coupled tothe sheath 4820 such that when the sheath retainer 4840 is moveddistally away from the base 4520 into a second (or removed) position,the sheath 4820 is removed from the needle.

The sheath retainer 4840 includes an actuator 4864 that is received byan opening 4862 in the isolation tab 4860. Accordingly, when the sheathretainer 4840 is moved distally away from the base 4520, the isolationtab 4860 is removed from the area between the first electrical contactportion 4936 of the printed circuit board 4922 and the first surface4964 of one of the batteries 4962. In this manner, the batteries 4962can be operatively coupled to the electronic circuit system 4920 whenthe needle guard 4810 is removed, thereby actuating the electroniccircuit system 4920.

When actuated, the electronic circuit system 4920 can output one or morepredetermined electronic outputs. For example, in some embodiments, theprocessor 4950 can output an electronic signal associated with recordedspeech to the audible output device 4956. Such an electronic signal canbe, for example, associated with a .WAV file that contains a recordedinstruction instructing the user in the operation of the auto-injector4002. Such an instruction can state, for example, “remove the bluesafety tab near the base of the auto-injector.” The processor cansimultaneously output an electronic signal to the first LED 4958A,thereby causing the first LED 4958A, which is located near the safetylock 4710, to flash a particular color. In this manner, the electroniccircuit system 4920 can provide both audible and visual instructions toassist the user in the initial operation of the auto-injector 4002.

In other embodiments, the electronic circuit system 4920 can output anelectronic output associated with a description and/or status of theauto-injector 4002 and/or the medicament contained therein. For example,in some embodiments, electronic circuit system 4920 can output anaudible message indicating the type of medicament contained in theauto-injector, the expiration date of the medicament, the dosage of themedicament or the like.

As illustrated by arrow BB in FIG. 13, the safety lock 4710 is removedby moving it substantially normal to the longitudinal axis of thehousing 4110. The safety lock 4710 has a first end 4712 and a second end4714. When the safety lock 4710 is in its first (or locked) position,the second end 4714 extends around a portion of the base 4520 to spacethe base 4520 apart from the distal end portion 4114 of the housing4110. Additionally, the first end 4714 includes a locking protrusion(not shown) that obstructs portions of the system actuator (not shown)further preventing the base 4520 from being moved proximally towards thehousing 4110. Accordingly, when the safety lock 4710 is in its firstposition, the auto-injector 4002 cannot be actuated.

In some embodiments, the safety lock 4710 includes an actuator 4732 thatactuates the electronic circuit 4920 to trigger a predetermined outputor sequence of outputs when the safety lock 4710 is moved from the firstposition to a second (or unlocked) position, as shown in FIG. 13. Moreparticularly, as shown in FIGS. 10, 15 and 16, the actuator 4732includes a protrusion 4730 that is received within a first opening 4928Adefined by an actuation portion 4926 of the substrate 4924 when thesafety lock 4710 is in the first position. The boundary 4929 of thefirst opening 4928A has a discontinuous shape, such as, for example, ateardrop shape, that includes a stress concentration riser 4930. Thediscontinuity and/or the stress concentration riser 4930 of the boundary4929 can be of any suitable shape to cause the substrate 4924 to deformin a predetermined direction when the protrusion 4730 is moved relativeto the first opening 4928A.

As shown in FIGS. 15 and 16, the first opening 4928A is defined adjacentan electrical conductor 4934 that, as discussed above, electronicallycouples the components included in the electronic circuit system 4920.The electrical conductor 4934 includes a first switch 4972A, which canbe, for example a frangible portion of the electrical conductor 4934. Inuse, when the safety lock 4710 is moved from the first position to thesecond position, the actuator 4732 moves in a direction substantiallyparallel to a plane defined by a surface of the actuation portion 4926of the substrate 4924. The movement of the actuator 4732 causes theprotrusion 4730 to move within the first opening 4928A, as indicated bythe arrow DD in FIG. 16. The movement of the protrusion 4730 tears theactuation portion 4926 of the substrate 4924, thereby separating theportion of the electrical conductor 4934 including the first switch4972A. Said another way, when the safety lock 4710 is moved to thesecond position, the actuator 4732 moves irreversibly the first switch4972A from a first state (e.g., a state of electrical continuity) to asecond state (e.g., a state of electrical discontinuity).

When the actuator 4732 actuates the electronic circuit system 4920 asdescribed above, the electronic circuit system 4920 can output one ormore predetermined electronic outputs. For example, in some embodiments,the processor 4950 can output an electronic signal associated withrecorded speech to the audible output device 4956. Such an electronicsignal can be, for example, associated with a recorded message notifyingthe user of the status of the auto-injector 4002. Such a status messagecan state, for example, “The auto-injector is now enabled.” Theprocessor can also simultaneously output an electronic signal to thefirst LED 4958A, thereby causing the first LED 4958A to stop flashing,change color or the like.

In some embodiments, the electronic circuit system 4920 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4920 can output an audiblemessage further instructing the user in the operation of theauto-injector 4002. Such an instruction can state, for example, “Placethe base of the auto-injector against the patient's thigh. To completethe injection, press the base firmly against the patient's thigh.” Insome embodiments, the processor can simultaneously output an electronicsignal to the second LED 4958B, thereby causing the second LED 4958B,which is located near the base 4520, to flash a particular color. Inthis manner, the electronic circuit system 4920 can provide both audibleand visual instructions to assist the user in the placement andactuation of the auto-injector 4002. In some embodiments, the electroniccircuit system 4920 can be configured to repeat the instructions after apredetermined time period has elapsed.

After the auto-injector 4002 is enabled and placed against the body ofthe patient, the auto-injector 4002 is actuated by moving the base 4520proximally towards the housing 4110, as illustrated by arrow CC in FIG.14. The base 4520 includes an actuator 4538 that actuates the electroniccircuit 4920 to trigger a predetermined output or sequence of outputswhen the base 4520 is moved from a first position to a second position,as shown in FIG. 13. The actuator 4538 includes a protrusion 4539 thatis received within a second opening 4928B (see FIG. 10) defined by thesubstrate 4924 when the base 4520 is in the first position. Theconfiguration and operation of the protrusion 4539, the second opening4928B and the second switch 4972B are similar to the configuration andoperation of the protrusion 4730, the first opening 4928A and the firstswitch 4972A, and are therefore not described in detail.

When the actuator 4538 actuates the electronic circuit system 4920, theelectronic circuit system 4920 can output one or more predeterminedelectronic outputs. For example, in some embodiments, the processor 4950can output an electronic signal associated with recorded speech to theaudible output device 4956. Such an electronic signal can be, forexample, associated with a recorded message notifying the user that theinjection is complete, instructing the user on post-injection disposaland safety procedures, instructing the user on post-injection medicaltreatment or the like. Such a status message can state, for example,“The injection is now complete. Please seek further medical attentionfrom a doctor.” The processor can also simultaneously output anelectronic signal to the first LED 4958A, thereby causing the first LED4958A to stop flashing, change color or the like, to provide a visualindication that the injection is complete.

As described above, the batteries 4962 are positioned such that thefirst electrical contact portions 4936 of the printed circuit board 4922can be placed in contact with the first surface 4964 of each battery4962 and the second electrical contact portion 4938 of the printedcircuit board 4922 can be placed in contact with the second surface 4966of each battery 4962. As shown in FIGS. 10 and 17, the first electricalcontact portions 4936 each include a pair of electrical contacts 4937that are operatively coupled to the electronic circuit system 4920.Similarly, the second electrical contact portion 4938 includes a pair ofelectrical contacts 4939 that is operatively coupled to the electroniccircuit system 4920.

The first electrical contact portions 4936 and the second electricalcontact portion 4938 are monolithically constructed from the printedcircuit board 4922. FIGS. 17-20 are perspective views showing theprinted circuit board 4922 in various stages of manufacture. FIG. 21 isa flow chart illustrating a method 5000 for manufacturing a flexibleprinted circuit board according to an embodiment of the invention. Theillustrated method includes disposing a copper layer on the top surface4925 of the flexible substrate 4924 and etching the desired series ofelectrical conductors (not shown in FIGS. 17-20) at 5002. A mask layer(not shown) is disposed on portions of the top layer 4925 of thesubstrate 4924 to electrically isolate selected portions of theelectrical conductors from adjacent components at 5004. During thisoperation, the electrical contacts 4937, 4939 are constructed.

The printed circuit board 4922 is then populated with themicroprocessor, switches, output devices and/or other electroniccomponents to form the electronic circuit system 4920 at 5006. Forclarity, the circuit components are not shown in FIGS. 17-20. After theprinted circuit board 4922 is populated, the portion of the flexiblesubstrate 4924 forming the second electrical contact portion 4938 isseparated from the remainder of the substrate 4924 at 5008. As shown inFIG. 17, during this operation, a portion 4923 of the boundary betweenthe second electrical contact portion 4938 and the remainder of thesubstrate 4924 is left intact.

As shown by the arrow EE in FIG. 18, the second electrical contactportion 4938 is then moved upwardly away from the remainder of thesubstrate 4924 at 5010. In this manner, the second electrical contactportion 4938 is spaced apart from the first electrical contact portions4936. As shown by the arrow FF in FIG. 19, the portion of the secondelectrical contact portion 4938 containing the electrical contacts 4939is then folded so that the electrical contacts 4939 on the secondelectrical contact portion 4938 are facing the electrical contacts 4937on the first electrical contact portions 4936, at 5012. In this manner,opposing electrical contacts 4937, 4939 are constructed on the printedcircuit board 4922 without disposing electrical conductors on and/oretching multiple surfaces of the printed circuit board 4922.

The batteries 4962 are then disposed between the first electricalcontact portions 4936 and the second electrical contact portion 4938 at5014. Although not shown in FIG. 19, in some embodiments, a batteryisolation tab of the type discussed above can be disposed between one ofthe batteries and the printed circuit board 4922. Once the batteries4962 are in place, the top layer 4911 of the label 4910 is disposedabout the printed circuit board 4922 (see FIG. 20) to maintain theposition of the batteries 4962 within the printed circuit board 4922, at5016. The label assembly 4910 is then coupled to the outer surface ofthe housing (not shown) at 5018. The label 4910 is coupled to thehousing with sufficient tension and/or stretch to maintain theelectrical contacts 4937 in electrical communication with the firstsurface 4964 of each battery 4962 and to maintain the electricalcontacts 4939 in electrical communication with the second surface 4966of each battery 4962. In this manner, the batteries 4962 can be held inplace in a printed circuit board 4922 devoid of springs, clips or otherrigid members.

As described above, the audio output device 4956, can include, forexample, a micro-speaker. In some embodiments, for example, the audiooutput device 4956 can include an RS-1511A micro-speaker manufactured byRegal Electronics, Inc.

Similarly, the microprocessor 4950 can be a commercially-availableprocessing device dedicated to performing one or more specific tasks.For example, in some embodiments, the microprocessor 4950 can be acommercially-available microprocessor, such as the Sonix SNC 12060 voicesynthesizer. Alternatively, the microprocessor 4950 can be anapplication-specific integrated circuit (ASIC) or a combination ofASICs, which are designed to perform one or more specific functions. Inyet other embodiments, the microprocessor 4950 can be an analog ordigital circuit, or a combination of multiple circuits.

The microprocessor 4950 can include a memory device (not shown)configured to receive and store information, such as a series ofinstructions, processor-readable code, a digitized signal, or the like.The memory device can include one or more types of memory. For example,the memory device can include a read only memory (ROM) component and arandom access memory (RAM) component. The memory device can also includeother types of memory suitable for storing data in a form retrievable bythe microprocessor 4950, for example, electronically-programmable readonly memory (EPROM), erasable electronically-programmable read onlymemory (EEPROM), or flash memory.

FIG. 22 is a flow chart illustrating a method 5040 for manufacturing amedical device according to an embodiment of the invention. The medicaldevice can be any medicament delivery device of the type discussedabove, such as, for example, an auto-injector, a pen injector, aninhaler, or a transdermal delivery device. The medical device can alsobe a medicament container, such as, for example, a pill bottle, ablister pack an intravenous solution bag or the like. The illustratedmethod includes assembling the medical device, 5042. After the medicaldevice is assembled, an electronic circuit system is placed on an outersurface of the medicament delivery device, 5044. The electronic circuitsystem can by any electronic circuit system of the type shown anddescribed above. In some embodiments, the electronic circuit system isplaced on the outer surface of the medical device in a predeterminedorientation. For example, in some embodiments, the electronic circuitsystem can include openings, such as openings 4928 that are aligned withmating portions of the medical device, such as, for example, protrusions4730, 4538. In other embodiments, however, the electronic circuit systemcan be placed on the outer surface of the medical device in anyorientation.

After the electronic circuit system is placed on an outer surface of themedical device, a label is coupled to the medical device, 5046. Thelabel, which can be, for example, a label containing a textual indicia,is coupled to the medical device such that a portion of the label isdisposed about the electronic circuit system. In this manner, thecoupling of the label to the medical device also serves to maintain theelectronic circuit system in its position against the outer surface ofthe medicament delivery device.

FIG. 23 is a flow chart illustrating a method 5060 for manufacturing amedical device according to an embodiment of the invention. The medicaldevice can be any medicament delivery device of the type discussedabove, such as, for example, an auto-injector, a pen injector, aninhaler, or a transdermal delivery device. The medical device can alsobe a medicament container, such as, for example, a pill bottle, ablister pack, an intravenous (IV) bag or the like. The illustratedmethod includes assembling the medical device, 5062. The medical deviceis then sterilized using any suitable sterilization process, 5064. Insome embodiments, for example, such as those embodiments in which themedicament is epinephrine, the medical device can be sterilized byexposure to ethylene oxide (EtO) gas. In other embodiments, the medicaldevice can be sterilized by exposure to gamma radiation. In yet otherembodiments, the medical device can be sterilized by exposure to heat,such as for example, by placing the medicament delivery device into anautoclave.

In parallel with the manufacture of the medical device, the illustratedmethod includes constructing an electronic circuit system of the typeshown and described above, 5066. The electronic circuit system is thencoupled to a label, 5068, to form a label assembly. Because the circuitconstruction is done apart from the manufacture of the medicamentdelivery device, it is not subjected the sterilization process, which,in some instances, may damage the circuit components.

The illustrated method then includes placing the label assembly on theouter surface of the medical device, 5070. The label assembly is thencoupled to the outer surface of the medical device, 5072. In someembodiments, the label assembly can be coupled to the medicamentdelivery device by an adhesive, an elastic fastener, a shrink wrap orany other suitable method.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although the first surface 4912 of the top layer 4911 ofthe label 4910 is shown and described as being opposite the secondsurface 4914 of the top layer 4911 of the label 4910, in otherembodiments, the first surface 4912 and the second surface 4914 can beadjacent each other and/or co-planar. Similarly, although the top layer4911 of the label 4910 is shown and described as covering substantiallyall of the housing 4110, in some embodiments, the top layer 4911 of thelabel 4910 can cover only a portion of the housing.

Although the label 4910 is shown and described as including a top layer4911, an intermediate layer 4980 and a printed circuit board 4922, insome embodiments, the layers comprising the label 4910 can be arrangedin any suitable order. For example, in some embodiments, a multi-layeredlabel can include a printed circuit board as an intermediate layer. Inother embodiments, a multi-layered label can include a printed circuitboard as the outer layer. Moreover, in yet other embodiments, the labelneed not include multiple layers. For example, in some embodiments, alabel can include a single layer that includes an electronic circuitsystem and textual indicia.

Although the indicia 4916 are shown and described as being visible(e.g., textual indicia and/or symbolic indicia), in some embodiments, alabel can include indicia that are haptic. For example, in someembodiments a label can include Braille. In other embodiments, a labelcan include indicia having a distinct feel, such as for example, aparticularly rough or smooth surface.

Although the electronic circuit system 4920 is shown and described asincluding a printed circuit board 4922 having a flexible substrate 4924,in other embodiments, an electronic circuit system can include a rigidprinted circuit board. In yet other embodiments, an electronic circuitsystem can include a printed circuit board having a substrate having atleast a rigid portion.

Moreover, in some embodiments, an electronic circuit system need notinclude a printed circuit board. For example, in some embodiments, anelectronic circuit system can include electronic components operativelycoupled by any suitable method other than by a printed circuit board.

Similarly, although the components included in the electronic circuitsystem 4920 (e.g., the microprocessor 4950, the LEDs 4958A and 4958B orthe like) are shown and described as being operatively coupled byelectrical conductors 4934, in other embodiments, the components can beoperatively coupled without being physically connected. For example, insome embodiments, at least a portion of the components included in anelectronic circuit system can be inductively coupled. In otherembodiments, at least a portion of the components included in anelectronic circuit system can be evanescently coupled.

Although the switches 4972A and 4972B are shown and described as being“tear-through” switches that are monolithically formed from theelectrical conductors 4934, in other embodiments, a switch can be formedseparately from the electrical conductors 4934. For example, in someembodiments, an electrical circuit system can include a series of firstelectrical conductors having a first set of characteristics (e.g., thewidth, height, material from which the conductor is fabricated or thelike) and a switch constructed from a second electrical conductor havinga second set of characteristics different than the first set ofcharacteristics. In other embodiments, a switch can be a separatecomponent, such as, for example, a microswitch, that is mounted to theprinted circuit board. In yet other embodiments, an electrical circuitsystem can include a “pop-out” switch that includes a biasing member tobias the switch in a predetermined state. In yet other embodiments, anelectrical circuit system can include a switch that is disposed at alocation other than on a printed circuit board.

Similarly, although the switches 4972A and 4972B are shown and describedas being irreversibly movable from a first state to a second state, inother embodiments, a switch can be reversibly movable between a firststate and a second state. Moreover, in yet other embodiments, a switchcan have more than two distinct states.

Although the actuators 4732, 4539 are shown and described as beingconfigured to move in a direction substantially parallel to the surfaceof the substrate 4924, in other embodiments, an actuator can beconfigured to actuate an electronic circuit system by moving in anydirection. For example, in some embodiments a circuit actuator can bemoved in a direction substantially normal to a portion of an electroniccircuit system.

Similarly, although the actuators 4732, 4539 are shown and described asactuating the switches 4972A and 4972B by tearing and/or deforming aportion of the substrate 4924, in other embodiments, a switch can bemoved from a first state to a second state without deforming thesubstrate. For example, in some embodiments, an electronic circuitsystem can include a printed circuit board having a substrate and afrangible switch tab disposed on the substrate. An electrical conductorand/or a switch can be disposed on the frangible switch tab, such thatwhen the switch tab is removed from the substrate the switch is movedfrom a first state to a second state. In this manner, the switch can beactuated without tearing and/or deforming a portion of the substrate.

Although the actuators 4732, 4539 are shown and described as beingincluded on the safety lock 4710 and the base 4520, respectively, inother embodiments, the actuators can be included on any component of amedicament delivery device. For example, in some embodiments, anauto-injector can include a start button having an actuator configuredto actuate an electronic circuit system. In other embodiments, anauto-injector can include a movable member configured to move amedicament container and/or a needle within a housing of theauto-injector, the movable member including an actuator configured toactuate an electronic circuit system.

Although the safety lock 4710 is shown and described as being removedfrom the housing 4110 of the auto-injector 4002 when in its secondposition, in other embodiments, a safety lock can remain coupled to thehousing of an auto-injector when in its second position. For example, insome embodiments, a safety lock can be moved from its first position toits second position by rotating a portion of the safety lock.

Certain components of the auto-injector 4002 are shown and described asbeing coupled together via protrusions and mating openings. Theprotrusions and/or openings can be disposed on any of the components tobe coupled together and need not be limited to only a certain component.For example, the safety lock 4710 is shown and described as including anactuator 4732 having a protrusion 4730 configured to be received withinan opening 4928A defined by the substrate 4924. In some embodiments,however, the protrusions can be disposed on the substrate 4924 and themating openings can be defined by the actuator 4732. In otherembodiments, such components can be coupled together in any suitableway, which need not include protrusions and mating openings. Forexample, in some embodiments, an actuator can be operatively coupled toan actuation portion of a substrate via mating shoulders, clips,adhesive or the like.

Similarly, although certain components of the auto-injector 4002 areshown and described as being constructed from multiple separatecomponents, in some embodiments, such components can be monolithicallyconstructed. For example, the needle guard 4810 and the batteryisolation tab 4860 are shown and described as being constructedseparately and then coupled together. In other embodiments, a needleguard and a battery isolation tab can be constructed monolithically.

Although the electronic circuit systems are shown and described above asbeing configured to output primarily audible and visual outputs, inother embodiments, an electronic circuit system can be configured toproduce any suitable output. For example, in some embodiments, anelectronic circuit system can produce a haptic output, such as avibratory output produced by a piezo-electric actuator. In otherembodiments, an electronic circuit system can produce a thermal output,produced by a heating or cooling element.

Similarly, the visual output devices shown and described above caninclude any suitable type of visual output device, such as, for example,a liquid crystal display, an organic polymer display, a fiber opticdisplay. In this manner, the visual output produced by an electroniccircuit system can include text messages, numerical indications of thedosage or the like.

Although the electronic circuit systems are shown and described above asoutputting recorded speech in English, in other embodiments, theelectronic circuit system can output recorded speech in any language. Inyet other embodiments, the electronic circuit system can output recordedspeech in multiple languages.

Although the electronic circuit systems are shown and described above asincluding a proximity sensor, in other embodiments, an electroniccircuit system can include any suitable sensor for providing feedback tothe electronic circuit system. For example, in some embodiments, theelectronic circuit system can include a pressure sensor configured tosense the internal gas pressure within a gas-powered auto-injector. Inthis manner, the electronic circuit system can output an instructionand/or a status message when the internal gas pressure crosses apredetermined threshold. For example, in some embodiments, when theinternal gas pressure rapidly increases, the electronic circuit systemcan output a message, such as, for example, “Internal gas chamber hasbeen successfully punctured—injection is in process.”

Similarly, in some embodiments, the electronic circuit system caninclude a temperature sensor configured to sense the temperature of themedicament contained within the medicament delivery device. In thismanner, the electronic circuit system can output an instruction and/or astatus message when the medicament is too cold for effective delivery.For example, in some embodiments, when the medicament is too cold foreffective delivery (this may occur, for example, if the medicamentdelivery device has been left outside overnight), the electronic circuitsystem can output a message, such as, for example, “Medicament is toocold—please briskly rub the auto-injector between your hands.”

Although the batteries 4962 are shown and described as having a firstsurface 4964 (an electrically negative terminal) and a second surface4966 (an electrically positive terminal) opposite the first surface, inother embodiments the batteries can include a first surface and a secondsurface that are adjacent each other and/or co-planar. In otherembodiments, an electronic circuit system can be powered by a batteryhaving any shape and/or any number of surfaces. In yet otherembodiments, an electronic circuit system can be powered by any suitableenergy storage device, such as, for example, a capacitor, solar cell,spring actuated generator, or the like.

Although the medicament delivery devices have been shown and describedabove as being primarily single-use medical injectors, in someembodiments a medicament delivery device can include any suitable devicefor delivering one or more doses of a medicament into a patient's body.For example, in some embodiments, a medicament delivery device can be apen injector containing multiple doses of a chronic-care medicament,such as, for example, insulin. In such embodiments, an electroniccircuit system can output instructions associated with not only aninitial use of the medicament delivery device, but also associated withrepeated uses, dosage monitoring or the like. In other embodiments, amedicament delivery device can include a transdermal medicament deliverydevice, an inhaler or a nasal medicament delivery device.

FIGS. 24 and 25 show an inhaler 6002 according to an embodiment of theinvention. The inhaler 6002 includes a housing 6110 and a medicamentcontainer 6262 movably disposed within the housing 6110. The medicamentcontainer 6262 includes a metering mechanism (not shown in FIGS. 24 and25) configured to discharge a predetermined volume of medicament whenthe inhaler 6002 is actuated.

The housing 6110 has a proximal end portion 6112 and a distal endportion 6114. An label 6910, which includes at least a portion of anelectronic circuit system 6920, is disposed on an outer surface 6111 ofthe housing 6110. As described above, a portion of the label 6910 caninclude a textual indicia 6916. Similar to the electronic circuitsystems shown and described above, the electronic circuit system 6920 isconfigured to output at least one electronic signal associated with theuser of the inhaler 6002. The electronic circuit system 6920 includes amicroprocessor (not shown), a microspeaker 6956 and an LED 6958. Theelectronic circuit system 6920 also includes a motion sensor 6976, thefunction of which is discussed in more detail below.

The distal end portion 6114 of the housing 6110 includes a mouthpiece6212 about which a protective cap 6710 is disposed. Prior to use, theinhaler 6002 is first enabled by removing the protective cap 6710, asshown by the arrow GG in FIG. 25. The protective cap 6710 includes anactuator 6732 that actuates the electronic circuit system 6920 totrigger a predetermined output or sequence of outputs when theprotective cap 6710 is removed. In some embodiments, the actuator 6732can include a protrusion that is received by an actuation portion of theelectronic circuit system 6920, in a similar manner as described above.In other embodiments, the actuator 6732 can be configured to engage amicroswitch that can be repeatedly moved between a first state and asecond state.

When actuated, the electronic circuit system 6920 can output one or morepredetermined electronic outputs. For example, in some embodiments, theelectronic circuit system 6920 can output an audible message via themicrospeaker 6956 instructing the user to “vigorously shake the inhalerfor five seconds.” The processor can simultaneously enable the motionsensor 6976.

Upon receiving a predetermined input from the motion sensor 6976, whichcan be any sensor suitable for detecting the rapid motion of the inhaler6002, the processor can then send an electronic signal to produce asecond audible message. Such a message can state, for example, “theinhaler is now sufficiently shaken and is ready for use.” In someembodiments, the electronic circuit system 6920 can also output aninstruction associated with the correct placement of the inhaler 6002.For example, the electronic circuit system 6920 can output an audiblemessage stating “please place the mouthpiece in your mouth and firmlypress down on the medicament container.” The electronic circuit system6920 can also simultaneously output a signal to the LED 6958 to providea visual indication of where the mouthpiece 6212 is located.

After the inhaler 6002 is enabled and placed within the mouth of thepatient, the inhaler 6002 is actuated by moving the medicament container6262 distally within housing 6110, as illustrated by arrow HH in FIG.25. In some embodiments, the medicament container 6262 can include anactuator (not shown) that actuates the electronic circuit 6920, in amanner similar to those described above, to trigger a predeterminedoutput or sequence of outputs. For example, in some embodiments, theprocessor can output an electronic signal associated with recordedspeech to the microspeaker 6956. Such an electronic signal can be, forexample, associated with a recorded message notifying the user that theinjection is complete, instructing the user on post-injectionprocedures, instructing the user on post-injection medical treatment orthe like. Such a status message can state, for example, “The injectionis now complete.”

In other embodiments, a medicament delivery device can include atransdermal medicament delivery device, such as for example, amedicament patch. In such embodiments, an electronic circuit system canbe configured, for example, to output instructions associated with theenablement, placement and/or removal of the transdermal medicamentdelivery device. For example, in some embodiments, the electroniccircuit system can be actuated by removing a protective barrier thatseals the portion of the device that contacts the skin.

Although the medical devices are shown and described above as beingmedicament delivery devices, such as, for example, medical injectors,inhalers or the like, in other embodiments, a medical device can includea medicament container, such as, for example, a pill bottle, a blisterpack or the like.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate.

What is claimed is:
 1. A method, comprising: receiving, in response toan actuator of a medicament delivery device moving relative to ahousing, a first electronic signal, the medicament delivery deviceconfigured to deliver a medicament in response to the actuatoractivating a non-electronic energy storage member; and sending, inresponse to receiving the first electronic signal, a second electronicsignal to a speaker to cause the speaker to emit an audible instructionassociated with a use of the medicament delivery device.
 2. The methodof claim 1, wherein the audible instruction is a recorded speech outputincluding a post-use instruction.
 3. The method of claim 1, wherein theaudible instruction is a recorded speech output confirming the deliveryof the medicament and prompting a user to seek medical attention.
 4. Themethod of claim 1, wherein the audible instruction is a first recordedspeech output including a post-use instruction, the method furthercomprising: receiving, third electronic signal before receiving thefirst electronic signal; and sending, in response to receiving the thirdelectronic signal, a fourth electronic signal to the speaker to causethe speaker to emit a second recorded speech output including a pre-useinstruction.
 5. The method of claim 1, wherein the audible instructionis a recorded speech output prompting a user to seek medical attention,the method further comprising: sending, in response to receiving thefirst electronic signal, a third electronic signal to a light outputdevice to cause the light output device to produce a visual indicationduring the audible instruction.
 6. The method of claim 1, wherein theaudible instruction is a first recorded speech output including apost-use instruction, and the actuator is configured to cause amedicament to be delivered when moved relative to the housing, themethod further comprising: receiving a third electronic signal beforethe receiving the first electronic signal, the third electronic signalreceived in response to a moveable member moving relative to thehousing, the moveable member configured to limit movement of actuatorrelative to the housing; and sending, in response to receiving the thirdelectronic signal, a fourth electronic signal to the speaker to causethe speaker to emit a second recorded speech output providing aninstruction identifying the actuator of the medicament delivery device.7. The method of claim 6, wherein the second recorded speech outputincludes an instruction for moving the actuator, the method furthercomprising: sending, in response to receiving the third electronicsignal, a fifth electronic signal to a light output device to cause thelight output device to produce a visual indication associated with theactuator.
 8. The method of claim 1, wherein the first electronic signalis received in response to a protrusion of the actuator moving a switch.9. The method of claim 1, wherein: the first electronic signal isreceived in response to a first portion of the actuator moving a switch;and a second portion of the actuator is configured to actuate thenon-electronic energy storage member.
 10. A non-transitory processorreadable medium storing code representing instructions to be executed bya processor, the code comprising code to cause the processor to: receivea first signal associated with movement of an actuator of a medicamentdelivery device relative to a housing of the medicament delivery device;identify an instruction stored in a memory associated with a use of themedicament delivery device, the instruction directing a user to seekmedical attention; and send, after delivery of a medicament from themedicament delivery device, a second signal to a speaker to cause thespeaker to produce a recorded speech output associated with theinstruction.
 11. The non-transitory processor readable medium of claim10, wherein the instruction is a first instruction and the recordedspeech output is a first recorded speech output, the code furthercomprising code to cause the processor to: receive a third electronicsignal before receiving the first electronic signal, the thirdelectronic signal associated with a cover being moved relative to themedicament delivery device; identify a second instruction stored in thememory, the second instruction providing directions for how to use themedicament delivery device; and send, in response to receiving the thirdelectronic signal, a fourth electronic signal to cause the speaker toproduce a second recorded speech output associated with secondinstruction.
 12. The non-transitory processor readable medium of claim10, further comprising code to cause the processor to: send, in responseto receiving the first signal, a third signal to cause a networkinterface to transmit data associated with movement of the actuator to aremote device.
 13. A method, comprising: placing a portion of amedicament delivery device into contact with a body; and actuating themedicament delivery device such that a non-electronic energy storagemember produces a force to deliver a medicament into the body, and suchthat a speaker produces an audible instruction after delivery of themedicament.
 14. The method of claim 13, wherein the audible instructionis a recorded speech output prompting a user to seek medical attention.15. The method of claim 13, wherein the actuating is performed such thata light output device produces a visual indication during the audibleinstruction.
 16. The method of claim 13, wherein the actuating includesmoving an actuator of the medicament delivery device such that aprotrusion of the actuator moves a switch to cause the speaker toproduce the audible instruction.
 17. The method of claim 13, wherein theactuating includes moving an actuator of the medicament delivery devicesuch that a first portion of the actuator moves a switch to cause thespeaker to produce the audible instruction and a second portion of theactuator actuates the non-electronic energy storage member.
 18. Themethod of claim 13, wherein the medicament delivery device includes anelectronic circuit system that includes the speaker, the method furthercomprising: removing, before the placing, a battery isolation memberfrom the medicament delivery device to electrically couple a powersource to the electronic circuit system.
 19. The method of claim 13,wherein the actuating includes moving an actuator of the medicamentdelivery device, the method further comprising: removing, before theplacing, a lock member from the actuator, at least a portion of the lockmember covering at least a portion of the actuator to limit movement ofthe actuator when the lock member is coupled to the actuator.
 20. Themethod of claim 19, wherein: the audible instruction is a first recordedspeech output prompting a user to seek medical attention; and theremoving the lock member is performed such that the speaker produces asecond recorded speech output providing an instruction identifying theactuator of the medicament delivery device.